Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendments
The amendment and response filed on November 12, 2025, to the Non-Final Office Action dated August 11, 2025 has been entered. Claims 1 - 20 are pending in this application.
Response to Arguments
Applicant’s arguments and amendments, see pages 8-10, filed November 11, 2025, with respect to the 35 U.S.C. § 103 rejection in various combinations of based on Robinson et al (US-20100228264-A1), Danziger et al (US-20170189096-A1), Wang et al (US-20030050733-A1), Shelton et al (US-20210322017-A1), and Wixey et al (JP-6914942-B2 having English equivalent of US-20190038371-A1) have been considered and are deemed to be unpersuasive. The 35 U.S.C. § 103 rejection of claims 1-20 is maintained for the reasons explained below.
Applicant asserts that “component 1318 of Danziger is not communicatively coupled to a control interface and a laparoscopic device, and furthermore is not configured to enable operation of the laparoscopic device from the control interface and directly from the laparoscopic device. Rather, component 1318 of Danziger is an adapter that electrically couples to a generator and utilizes charging technology from the generator to generate DC output. See paragraph [0128].” (cited with emphasis).
The Examiner disagrees, it is noted that the features upon which applicant relies (i.e., dongle being a substitute interface for both the laparoscopic device and the control interface ) are not recited in the rejected claim(s). The claims are more broadly claimed than how applicant interprets them, so that a broader but reasonable interpretation, as has been done by the rejection, does not necessitate such requirement as applicant argued. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In this case, the claim only recites using an “interface ECU (90) configured to facilitate communication between said harvester control unit (75) and a cloud (100)" and does not recite an interface that selects harvester functions and parameters for communication as applicant asserts. Applicant is reminded USPTO personnel are to give claims their broadest reasonable interpretation in light of the supporting disclosure. In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997). Limitations appearing in the specification but not recited in the claim should not be read into the claim. E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1369, 67 USPQ2d 1947, 1950 (Fed. Cir. 2003) (claims must be interpreted "in view of the specification" without importing limitations from the specification into the claims unnecessarily). In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-551 (CCPA 1969). See also In re Zletz, 893 F.2d 319, 321-22, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989) ("During patent examination the pending claims must be interpreted as broadly as their terms reasonably allow.... The reason is simply that during patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.... An essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous. Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process.").
As interpreted all the dongle is required to do is couple to the control interface and/or to the laparoscopic device so as to be operational by a user using the respective interfaces. Additionally, since Donziger discloses using “RF antennas and inductive charging”, see at least Para. [0157], and the use of rapidly-charging supercapacitors it is reasonable to conclude that a charger such as the identified component 1318 of Danziger can communicatively couple (“RF Antenna”) to the respective interface so as to charge them so it can be used by the operator to meet the requirements of the claims.
Thus, the claims are more broadly claimed than how applicant interprets them and applicant's argument is not deemed persuasive to overcome the rejection, and the rejection is maintained.
Claim Rejections -- 35 U.S.C. § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 15, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Robinson et al (US-20100228264-A1)(“Robinson”) and Danziger et al (US-20170189096-A1)(“Danziger”), both references supplied by Applicant in IDS filed on 10/8/2024.
Regarding claim 1, Robinson discloses: A surgical control system (150, 151, FIG.1A, para [0044] "A computer 151 of the console 150 directs movement of robotically controlled endoscopic surgical instruments (generally numbered 101 ), effecting movement of the instruments using_ a robotic surgical manipulator 152.") for use with a computerized surgical manipulation system (101N8, FIG.1A, para [0043] "Referring now to FIG. 1A, a block diagram of a robotic surgery system 1 00A is illustrated to perform minimally invasive robotic surgical procedures using robotic electrosurgical tools 101A and 1018."), comprising:
(a) a control interface (150, 151, FIG. 1A, para [0046] "The driven portion of the robotic surgical manipulator 152 is actively articulated under the direction of the operator O generating control signals at the surgeon's console 150 during surgery."; para [0047] "The one or more electrosurgical generators 102A-1028 are remotely controlled by the master console 150 over the control cables 109A-1098 by a surgeon operating the master console."), communicatively coupled to a laparoscopic device detached from a robot (101A, 1018, FIG.1A, para [0042] "One or more of the robotic manipulator arms are often used to support a surgical image capture device such as an endoscope (which may be any of a variety of structures such as a laparoscope, an arthroscope, a hysteroscope, or the like), or, optionally, some other imaging modality (such as ultrasound, fluoroscopy, magnetic resonance imaging, or the like)."; para [0043] "Referring now to FIG. 1A, a block diagram of a robotic surgery system 100A is illustrated to perform minimally invasive robotic surgical procedures using robotic electrosurgical tools 101A and 1018. Each of the robotic electrosurgical tools 101 A and 1018 are robotic endoscopic surgical instrument that are manipulated by a slaved robotic manipulator and remotely controlled by control signals received from a master control console. "; para [0062] "The robotic surgical tools 101 are generally sterile structures, often being sterilizable and/or being provided in hermetically sealed packages for use. As the robotic surgical tools 101 will be removed and replaced repeatedly during many procedures, a tool holder could potentially be exposed to contamination if the interface directly engages the tool holder. To avoid contamination to a tool holder and possible cross contamination between patients, an adaptor for coupling to robotic surgical tools 101 is provided in a robotic arm of the robotic surgical manipulator."), of a computerized surgical manipulation system (100A, FIG. 1A, para [0043]-[0045] "Referring now to FIG. 1A, a block diagram of a robotic surgery system 1 00A is illustrated to perform minimally invasive robotic surgical procedures using robotic electrosurgical tools 101 A and 1018. Each of the robotic electrosurgical tools 101A and 1018 are robotic endoscopic surgical instrument that are manipulated by a slaved robotic manipulator and remotely controlled by control signals received from a master control console. In contrast, manual endoscopic surgical instruments are directly controlled by hand. Robotic electrosurgical tool 101A is a bipolar electrosurgical tool. Robotic electrosurgical tool 1018 is a monopolar electrosurgical tool. A user or operator O (generally a surgeon) performs a minimally invasive surgical procedure on patient P by manipulating input devices at a master control console 150. The master control console 150 may also be referred to herein as a control console, a surgeon console, or a master console. A computer 151 of the console 150 directs movement of robotically controlled endoscopic surgical instruments (generally numbered 101 ), effecting movement of the instruments using a robotic surgical manipulator 152. The robotic surgical manipulator 152 may also be referred to as robotic patient-side cart system or simply as a cart. The robotic surgical manipulator 152 has one or more robotic arms 153. Typically, the robotic surgical manipulator 152 includes at least three robotic manipulator arms 153 supported by linkages, with a central arm supporting an endoscopic camera 101 C and the robotic surgical arms 153 to left and right of center supporting tissue manipulation tools and the robotic surgical tool 101 A. An assistant A may assist in pre-positioning of the robotic surgical manipulator 152 relative to patient P as well as swapping tools or instruments 101 for alternative tool structures, and the like, while viewing the internal surgical site via an assistant's display 154. The image of the internal surgical site shown to A by the assistant's display 154 and operator O by surgeon's console 150 is provided by one of the surgical instruments 101 supported by the robotic surgical manipulator 152."), wherein the control interface is positioned at a location physically remote from the laparoscopic device (master control console remotely controls the laparoscopic device and see FIG. 1A, 18 where 150 is remote from the device para [0043] "Each of the robotic electrosurgical tools 101A and 1018 are robotic endoscopic surgical instrument that are manipulated by a slaved robotic manipulator and remotely controlled by control signals received from a master control console."); and
Robinson, however, does not explicitly disclose: (b) a dongle communicatively coupled to the control interface and the laparoscopic device, wherein the dongle is configured to enable operation of the laparoscopic device from the control interface and directly from the laparoscopic device.
However, Danziger discloses: an electrosurgical system to control laparoscopic surgical devices (abstract, para [00031) and further discloses:
(b) a dongle communicatively coupled to the control interface and the laparoscopic device, wherein the dongle is configured to enable operation of the laparoscopic device from the control interface and directly from the laparoscopic device (Danziger at device 1318 controls the device by passing power as required FIG. 18, para [0128]-[0129] "FIG. 18 shows a diagram of an, electrosurgical system 1300 that includes an adapter 1318 that electrically couples to a generator, such as any of the generators described herein, and utilizes charging technology from the generator to generator DC output for various uses. As shown in FIG. 18, a generator is coupled to the adapter 1318. The generator provides various inputs to the adapter 1318, including a first energy modality power input 1304, a second energy modality power input 1306, and a common return 1308."; para [0158] "The surgical instruments described herein can also include features to allow the energy being delivered by the generator to be dynamically changed based on the type of tissue being treated by an end effector of a surgical instrument and various characteristics of the tissue.").
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system as taught by Robinson with the adapter for a surgical instrument as taught by Danziger with a reasonable expectation of success in order for the one or more method steps to have alternate connection to a surgical device. The teaching suggestion/motivation to combine is that it allows. for efficiently controlling the energy profile as required for the procedure based on the type of tissue being effected by the end effector (Danziger, para [01581).
Regarding claim 15, Robinson as modified by Danziger discloses the surgical control system of claim 1.
Furthermore, Robinson discloses: wherein the detached laparoscopic device is supported by a trained individual positioned bedside to a patient (surgeon and assistant, para [0044] "A user or operator O (generally a surgeon) performs a minimally invasive surgical procedure on patient P by manipulating input devices at a master control console 150."; para [0045] "An assistant A may assist in pre-positioning of the robotic surgical manipulator 152 relative to patient Pas well as swapping tools or instruments 101 for alternative tool structures, and the like, while viewing the internal surgical site via an assistant's display 154.").
Regarding claim 16, Robinson as modified by Danziger discloses the surgical control system of claim 1.
wherein the dongle is incorporated into the laparoscopic device (Danziger at FIG. 11 discloses adapter coupled to device 9007, 9008 etc., para [0110] "FIG. 11 illustrates a communication architecture of system 1101 of a generator 1103 and surgical instruments 9007, 9008 shown in FIG. 9. According to FIG. 11, the generator 1103 is configured for delivering multiple energy modalities to a plurality of surgical instruments."; para [0112] "The switching mechanism 1123 is configured to receive the combined energy power output 1105 from the generator 1103 and it may be provided to the energy storage device 1125, surgical instrument 9007, and/or surgical instrument 9008."; para [0113] "The control circuit 1119 is coupled to the serial PIO integrated circuit 1133 and the serial PIO integrated circuit 1133 is coupled to the handpiece serial interface 1113 of the generator 1103. The control circuit 1119 may receive information regarding charger status flags and switching controls from the serial PIO integrated circuit 1133. Further, the . control circuit 1119 is coupled to the handswitch switching mechanism 1135, the handpiece switching mechanism 1137, and the presence switching mechanism 1139.").
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Robinson and Danziger as applied to claim 1 above, and further in view of Wang et al. (US-20030050733-A1)(“Wang”) ”), all references supplied by Applicant in IDS filed on 10/8/2024.
Regarding claim 2, Robinson as modified by Danziger discloses the surgical control system of claim 1.
Robinson and Danziger do not explicitly disclose: wherein the control interface or the dongle includes an override feature that, when activated, disables direct operation from the laparoscopic device, but maintains operation of the laparoscopic device from the control interface.
However, Wang discloses: a medical system controlled by 2 input devices for minimally invasive surgery (abstract, para [0017]) and further discloses: wherein the control interface or the dongle includes an override feature that, when activated, disables direct operation from the laparoscopic device, but maintains operation of the laparoscopic device from the control interface (FIG. 3, para [0024] ~FIG. 3 shows a system 100 that allows two different input devices to control one medical device. The input devices may be a first console 102 and a second console 104. The consoles 102 and 104 may each include the screen 36, handles 42 and 44, foot pedal (not shown) and controller 38 shown in FIG. 1. The medical devices may include the robotic arms 26, 28 and 30 and/or instruments 22 and 24 shown in FIG. 1. In general, the system allows a surgeon at either console 102 or 104 to control a medical device 22, 24, 26, 28 and or 30. For example, the surgeon at console 102 can move the robotic arms 26 and 28 through movement of the handles 42 and 44. The surgeon at console 104 can override the input from console 102 and control the movement of the robotic arms 26 and 28 through the movement of the console handles.").
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have included the method of overriding direct operation as per Wang for the system of Robinson and Danziger since it allows for robotic control or manual control as required only through the control console (Wang, para [0046], Robinson, para [0044]).
Claims 3, 4 and 8-14 are rejected under 35 U.S.C. 103 as being unpatentable over Robinson and Danziger as applied to claim 1 above, and further in view of Shelton et al (US-20210322017-A1)(“Shelton”), all references supplied by Applicant in IDS filed on 10/8/2024.
Regarding claim 3, Robinson as modified by Danziger discloses the surgical control system of claim 1. Furthermore, Robinson discloses: wherein the laparoscopic device is a surgical stapler configured to staple an anatomical structure of a patient (para [0050] "The remote controlled supply equipment may be used to supply vacuum, gasses, liquids, energy (e.g., electrical, laser. ultrasound), mechanical torques, mechanical push/pull forces, data signals, control signals, etc. to support functions of other types of robotic surgical tools (e.g., ultrasound, lasers, staplers)"), during a minimally invasive procedure (para [00441 "A user or operator O (generally a surgeon) performs a minimally invasive surgical procedure on patient P by manipulating input devices at a master control console 150. ") the surgical stapler comprising:
(a)an end effector having a clamping mechanism (Robinson at para [0069] "When mounted to a robotic surgical arm 153, end effectors may have a plurality: of degrees of freedom of movement relative to arm 153,-in addition to actuation movement of the end effectors. The end effectors of the robotic surgical tool are used in performing a surgical operation ·such as cutting, shearing, grasping, gripping, clamping, engaging, or contacting tissue adjacent a surgical site. With an electrosurgical tool, a conductor electrically communicates with at least one of the end effectors to deliver electrical energy to tissue clamped by the gripping jaws.");
However Robinson and Danziger do not explicitly disclose an anvil assembly and a cartridge assembly, (b)an operating system comprising a trigger having an up-switch· and a down-switch, wherein activation of the up-switch opens the clamping mechanism, and wherein activation of the down-switch closes the clamping mechanism.
However, Shelton discloses: an interactive surgical systems with a robotic system (abstract, FIG.1-3) and further discloses: The end effector: with an anvil assembly and a cartridge assembly (Shelton at para [1082] "The first jaw 6532 may be configured to fire at least one fastener a plurality of times, or may be configured to include a replaceable multi-fire fastener cartridge including a plurality of fasteners (e.g., staples, clips, etc.) that may be fired more than one time prior to being replaced. The second jaw 6534 may include an anvil that deforms or otherwise secures the fasteners about tissue as the fasteners are ejected from the multi-fire fastener cartridge."), (b) an operating system comprising a trigger having an up-switch and a down-switch, wherein activation of the up-switch opens the clamping mechanism. and wherein activation of the down-switch closes the clamping mechanism (Shelton at para [1082] "The first and second jaws 6532, 6534 are configured to clamp tissue therebetween, fire fasteners through the clamped tissue, and sever the clamped tissue."; para [1083] "The handle 6504 includes a motor that is coupled to the drive shaft to affect rotation of the drive shaft. The handle 6504 includes a control interface to selectively activate the motor. The control interface may include buttons, switches, levers, sliders, touchscreen, and any other suitable input mechanisms or user interfaces, which can be engaged by a clinician to activate the motor.").
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have included the anvil and cartridge assembly and further including a switch to control the clamp mechanism as per Shelton for the system of Robinson and Danziger since it allows for controlling by holding the tissue and also perform various surgical operations such as severing the clamped tissue as required (Shelton, para [1082]-[1084]).
Regarding claim 4, Robinson as modified by Danziger and Shelton discloses the surgical control system of claim 3.
wherein the control interface is a foot-operable device comprising a plurality of input controls, wherein each of the input controls, when activated, communicate with the operating system of the surgical stapler to perform an action (Robinson at para [0054] "Smart cables 112A-112N may be respectively coupled between the one or more pieces of remote controllable equipment 102A-102N and the computer 151B in the control cart 150B. With these connections, the surgeon's console can control the remote controllable equipment with its foot pedals and master controllers. In this manner, the control of the remote controllable equipment 102A-102N may be integrated into the surgeon's console. Its foot pedals and master controllers become integrated control mechanisms that a surgeon may use to control every aspect of the surgical system to _make robotic surgery more efficient.").
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have included the foot operable devices with control as per the other embodiment of Robinson for the system of Robinson and Danziger and Shelton since it allows for providing improved control and feedback of operating the remote controllable equipment with the robotic surgical tools (Robinson, para [0054]).
Regarding claim 8, Robinson as modified by Danziger and Shelton discloses the surgical control system of claim 4. Furthermore, Robinson discloses: wherein the plurality of input controls include buttons, switches, pedals, or combination thereof (pedals, para [0054] "Smart cables 112A-112N may be respectively coupled between the one or more pieces of remote controllable equipment 102A-102N and the computer 151B in the control cart 150B. With these connections, the surgeon's console can control the remote controllable equipment with its foot pedals and master controllers. In this manner, the control of the remote controllable equipment 102A- 102N may be integrated into the surgeon's console. Its foot pedals and master controllers become integrated control mechanisms that a surgeon may use to control every aspect of the surgical system to make robotic surgery more efficient.").
Regarding claim 9, Robinson as modified by Danziger and Shelton discloses the surgical control system of claim 4. wherein the foot-operable device is integrated into a surgical console of the computerized surgical manipulation system (Robinson at para [0054] "Smart cables 112A-112N may be respectively coupled between the one or more pieces of remote controllable equipment 102A-102N and the computer 151 B in the control cart 150B. With these connections, the surgeon's console can control the remote controllable equipment with its foot pedals and master controllers. In this manner, the control of the remote controllable equipment 102A-102N may be integrated into the surgeon's console. Its foot pedals and master controllers become integrated control mechanisms that a surgeon may use to control every aspect of the surgical system to make robotic surgery more efficient.").
Regarding claim 10, Robinson as modified by Danziger and Shelton discloses the surgical control system of claim 3. wherein the control interface is a hand-operable device positioned on an exterior of a surgeon console of the computerized surgical manipulation system, the hand-operable device comprising· a plurality of input controls, wherein each of the input controls, when activated, communicate with the operating system of the surgical stapler to perform an action (Robinson at paras [0092]-[0093] "Referring now to FIGS. 3A-3C and FIG. 9, a left master controller 905L and a right master controller 905R (including master grip 325) in the workspace 316 can be used to generate control signals for the patient side cart 152 to control the robotic arms and the surgical tools mounted thereto. The left master controller 905L and the right master controller 905R are positioned in the workspace 316 disposed beyond the arm support 314 and below the viewer 312. When using the master control console 150,150A, the operator O (surgeon or user) typically sits in a chair, moves his or her head into alignment with the viewer 312, and couples his/her fingers to the master grips 325 of left master controller 905L and the right master controller 905R, one in each hand, while resting their forearms against the arm rest 314. This allows the master grips 325 of the left master controller 905L and the right master controller 905R to be moved easily in the control space 316_in both position and orientation to generate control signals.").
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have included the foot operable devices with control as per the other embodiment of Robinson for the system of Robinson and Danziger and Shelton since it allows for providing improved control and feedback of operating the remote controllable equipment with the robotic surgical tools (Robinson, para [0092]-[0093]).
Regarding claim 11, Robinson as modified by Danziger and Shelton discloses the surgical control system of claim 10. wherein the plurality of input controls include buttons or switches which, when activated, open the clamping mechanism, close the clamping mechanism, enter a firing mode, or combinations thereof (Robinson teaches switches control the robotic surgical system, para [0054] "Smart cables 112A-112N may be respectively coupled between the one or more pieces of remote controllable equipment 102A-102N and the computer 151 B in the control cart 150B. With these connections, the surgeon's console can control the remote controllable equipment with its foot pedals and master controllers. In this manner, the control of the remote controllable equipment 102A-102N may be integrated into the surgeon's c6nsole. Its foot pedals and master controllers become integrated control mechanisms that a surgeon may use to control every aspect of the surgical system to make robotic surgery more efficient."; para [0130} "Each of the horizontal switch assembly may further include a sensing device 727 to sense when a foot is over the pedal and ready to press down to close the switch and generate a control signal to control the robotic surgical system.")
It would have been obvious to a person of ordinary skill in the art to have included the switching devices with control as per the other embodiment of Robinson for the system of Robinson and Danziger and Shelton since it allows for providing improved control and feedback of operating the remote controllable equipment with the robotic surgical tools (Robinson, para [0054]).
Regarding claim 12, Robinson as modified by Danziger and Shelton discloses the surgical control system of claim 10. wherein the hand-operable device is a hand control that moves with one or more degrees of freedom, or a control panel · (Robinson at para [0092]-[0093] "Referring now to FIGS. 3A-3C and FIG. 9, a left master controller 905L and a right master controller 905R (including master grip 325) in the workspace 316 can be used to generate control signals for the patient side cart 152 to control the robotic arms and the surgical tools mounted thereto. The left master controller 905L and the right master controller 905R are positioned in the workspace 316 disposed beyond the arm support-314 and below the viewer 312. When using the master control console 150,150A, the operator 0 (surgeon or user) typically sits in a chair, moves his or her head into alignment with the viewer 312, and couples his/her fingers to the master grips 325 of left master controller 905L and the right master controller 905R, one in each hand, while resting their forearms against the arm rest 314. This allows the master grips 325 of the left master controller 905L and the right master controller 905R to be moved easily in the control space 316 in both position and orientation to generate control signals.").
Regarding claim 13, Robinson as modified by Danziger and Shelton discloses the surgical control system of claim 3. wherein the control interface is an audio recognition device having a microcontroller (Shelton speech interface recognizes voice commands, para [1.094] "Although a foot pedal is shown and described, it is to be understood that the input device 6560 may be a hand controller, a speech interface which accepts voice commands from the surgeon, a cantilever pedal or other input devices which may be well known in the art of surgical device control. Using the speech interface, the surgeon is able to position a camera or endoscope connected to the robotic arm 6552 using verbal commands.") configured to: (a) receive audio content from an audio capture device during the minimally invasive procedure, wherein the audio content is one or more instructions from a user; (b) analyze the audio content to-determine a meaning for the one or more-instructions: and (c) provide a command to the surgical stapler to perform one or more actions based on the meaning of the one or more instructions (Shelton para [1089]-[1090] "The system 6550 may be adapted and configured to operate a positioning system for an imaging device such as a camera or endoscope using verbal commands. The surgical device 6552 may be a robotic arm which can hold and move a surgical instrument . The system 6550 allows the surgeon to control the operation of the robotic arm 6552 through the input device 6560. "; para [1094] "Although a foot pedal is shown and described, it is to be understood that the input device 6560 may be a hand controller, a speech interface which accepts voice commands from the surgeon, a cantilever pedal or other input devices which may be well known in the art of surgical device control. Using the speech interface, the surgeon is able to position a camera or endoscope connected to the robotic arm 6552 using verbal commands. The imaging device, such as a camera or endoscope, may be coupled to the robotic arm 6552 positioning system that be controlled through the system 6550 using verbal commands.").
Regarding claim 14, Robinson as modified by Danziger and Shelton discloses the surgical control system of claim 13. wherein the one or more actions include opening the clamping mechanism, closing the clamping mechanism, enter a firing mode, or combinations thereof (Shelton teaches a stapling controlled by selecting channel of the device, para [1099] "The select channel 6592 may be connected by line 6594 to a dedicated button 6596 on the foot pedal 6560. The surgeon can switch surgical devices by depressing the button 6596. Alternatively, the select channel 6592 may be coupled by line 6598 to a speech interface 6600 which allows the surgeon to switch surgical devices with voice commands."; para [1159] • Additional surgical instruments 6939, 6940 are inserted through additional trocar sleeves 6900 which extend through body wall 6931. In FIG. 147, instrument 6939 schematically illustrates an endoscopic stapling device, e.g., an Endo GIA* instrument manufactured by the assignee of this application, and instrument 6940 schematically illustrates a hand instrument, e.g., an Endo Grasp* device also manufactured by the present assignee.").
Claims 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Robinson et al (US-20100228264-A1)(“Robinson”), Shelton et al (US-20210322017-A1)(“Shelton”), and Danziger et al (US-20170189096-A1)(“Danziger”), all references supplied by Applicant in IDS filed on 10/8/2024.
Regarding claim 17, Robinson discloses: A surgical control system (150, 151, FIG.1A, para [0044] "A computer 151 of the console 150 directs movement of robotically controlled endoscopic surgical instruments (generally numbered 101 ), effecting movement of the instruments using a robotic surgical manipulator 152.") for use with• a computerized surgical manipulation system (101A/B, FIG.1A, para [0043] "Referring now to' FIG. 1A, a block diagram of a robotic surgery system 100A is illustrated to perform minimally invasive robotic surgical procedures using robotic electrosurgical tools 101A and 101 B."), comprising: • (a) a surgical stapler configured to staple an anatomical structure of a patient (para [0050] "The remote controlled supply equipment may be used to supply vacuum, gasses, liquids, energy (e.g., electrical, laser, ultrasound), mechanical torques, mechanical push/pull forces, data signals, control signals, etc. to support functions of other types of robotic surgical tools (e.g., ultrasound, lasers, staplers)."), during a minimally invasive procedure (para [0044] "A user or operator O (generally a surgeon) performs a minimally invasive surgical procedure on patient P by manipulating input devices at a master control console 150."), (b) a control interface communicatively coupled to stapling device (150, 151, FIG. 1A, para [0046] "The driven portion of the robotic surgical manipulator 152 is actively articulated under the direction of the operator O generating control signals at the surgeon's console 150 during surgery."; para [0047] "The one or more electrosurgical generators 102A-102B are remotely controlled by the master console 150 over the control cables 109A-109B by a surgeon operating the master console."), wherein the control interface is positioned at the computerized surgical manipulation system physically remote from the stapling device (master control console remotely controls the laparoscopic device and see FIG. 1A,1B where 150 is remote from the device para [0043] "Each of the robotic electrosurgical tools 101A and 101 B are robotic endoscopic surgical instrument that are manipulated by a slaved robotic manipulator and remotely controlled by control signals received from a master control console."); and
wherein the surgical stapler is separate from the computerized surgical manipulation system and supported by a trained individual positioned bedside to the patient (it is the tool at the end of the robotic arm, surgeon and assistant, para [0044] "A user or operator O (generally a surgeon) performs a minimally invasive surgical procedure on patient P by manipulating input devices at a master control).
However Robinson does not explicitly disclose that the surgical stapler including: (i) an end effector having a clamping mechanism with an anvil assembly and a cartridge assembly; and
(ii) an operating system comprising a trigger having an up-switch and a down switch, and wherein activating the up-switch opens the clamping mechanism, wherein activating the down-switch closes the clamping mechanism;
(c) a dongle. communicatively coupled° to the control interface and the stapling device, wherein a microcontroller of the dongle is configured to enable operation of the stapling device from the control interface and directly from the stapling device, wherein the control interface or the dongle includes an override feature that, when activated, disables direct operation from the surgical device, but maintains operation of the surgical device from the control interface.
Robinson does, however, disclose a surgical stapler comprising: (a)an end effector having a clamping mechanism (Robinson at a [0069] "When mounted to a robotic surgical arm 153, end effectors may have a plurality of degrees of freedom of movement relative to arm 153, in addition to actuation movement of the end effectors. The end effectors of the robotic surgical tool are used in performing a surgical operation such as cutting, shearing, grasping, gripping, clamping, engaging, or contacting tissue adjacent a surgical site. With an electrosurgical tool, a conductor electrically communicates with at least one of the end effectors to deliver electrical energy to tissue clamped by the gripping jaws.");
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have included the end effector with a clamp as per the other embodiment of Robinson since it allows for performing various operations such as cutting, clamping as required (para (0069]).
Robinson does not explicitly disclose: an end effector: with an ·anvil assembly and a cartridge assembly;
and (ii) an operating system comprising a trigger having an up-switch and a downswitch, and wherein activating the up-switch opens the clamping mechanism, wherein activating the down-switch closes the clamping mechanism;
(c) a dongle communicatively coupled to the control interface and the stapling device, wherein a microcontroller of the dongle is configured to enable operation of the stapling device from the control interface and directly from the stapling device, wherein the control interface or the dongle includes an override feature that, when activated, disables direct operation from the surgical device, but maintains operation of the surgical device from the control interface.
Shelton in the same field of endeavor discloses: an interactive surgical systems with a robotic system (Shelton at abstract, FIG.1-3) and further discloses: ' . The end effector: with an anvil assembly and a cartridge assembly (para [1082] "The first jaw 6532 may be configured to fire at least one fastener a plurality of times, or may be configured to include a replaceable multi-fire fastener cartridge including a plurality of fasteners (e.g., staples, clips, etc.) that may be fired more than one time prior to being replaced. The second jaw 6534 may include an anvil that deforms or otherwise secures the fasteners about tissue as the fasteners are ejected from the multi-fire fastener cartridge.");
and (ii) an operating system comprising-a trigger having an up-switch and a down switch, and wherein activating the up-switch opens the clamping mechanism,-wherein activating the down-switch closes the clamping mechanism (Shelton at para [1082] "The first and second jaws 6532, 6534 are configured to clamp tissue therebetween, fire fasteners through the clamped tissue, and sever the clamped tissue."; para [1083] "The handle 6504 includes a motor that is coupled to the drive shaft to affect rotation of the drive shaft. The handle 6504 includes a control interface to selectively activate the motor. The control interface may include buttons, switches, levers, sliders, touchscreen, and any other suitable input mechanisms or user interfaces, which can be engaged by a clinician to activate the motor.").
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have included the anvil and cartridge assembly and further including a switch to control the clamp mechanism as per Shelton for the system of Robinson since it allows for controlling by holding the tissue and also perform various surgical operations such as severing the clamped tissue as required ( Shelton, para [1082]-[1084]).
Robinson and Shelton do not disclose: (c) a dongle communicatively coupled to the control interface and the stapling device, wherein a microcontroller of the dongle is configured to enable operation of the stapling device from the control interface and directly from the stapling device, wherein the control interface or the dongle includes an override feature that, when activated, disables direct operation from the surgical device, but maintains operation of the surgical device from the. control interface.
Danziger in the same field of endeavor discloses: an electrosurgical system to control laparoscopic surgical devices (abstract, para [00031) and further discloses: (c) a dongle communicatively coupled to the control interface and the stapling device, wherein a microcontroller of the dongle is configured to enable operation of the stapling device from the control interface and directly from the stapling device, wherein the control interface or the dongle includes an override feature that, when activated, disables direct operation from the surgical device, but maintains operation of the surgical device from the control interface (Danziger discloses at process 1318 controls the device by passing power as required FIG. 18, para [0128]-[0129] "FIG. 18 shows a diagram of an electrosurgical system 1300 that includes an adapter 1318 that electrically couples to a generator, such as any of the generators described herein, and utilizes charging technology from the generator to generator DC output for various uses. As shown in FIG. 18, a generator is coupled to the adapter 1318. The generator provides various inputs to the adapter 1318, including a first energy modality power input 1304, a second energy modality power input 1306, and a common return 1308."; para [0158] "The surgical instruments described herein can also include features to allow the energy being delivered by the generator to be dynamically changed based on the type of tissue being treated by an end effector of a surgical instrument and various characteristics of the tissue.").
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have included the adapter as per Danziger for the system of Robinson and Shelton since it allows for efficiently controlling the energy profile as required for the procedure based on the type of tissue being effected by the end effector (Danziger, para [0158]) .
Regarding claim 18, Robinson as modified by Shelton and Danziger discloses the surgical control system of claim 17. wherein the control interface is a foot-operable device comprising a plurality of input controls, wherein each of the input controls, when activated, communicate with the operating system of the surgical stapler to perform an action (Robinson at para [0054) "Smart cables 112A-112N may be respectively coupled between the one or more pieces of remote controllable equipment 102A-102N and the computer 1518 in the control cart 1508. With these connections, the surgeon's console can control the remote controllable equipment with its foot pedals and master controllers. In this manner, the control of the remote controllable equipment 102A-102N may be integrated into the surgeon's console. Its foot pedals and master controllers become integrated control mechanisms that a surgeon may use to control every aspect of the surgical system to make robotic surgery more efficient."). '
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have included the foot operable devices with control as per the other embodiment of Robinson for the system of Robinson and Shelton and Danziger since it allows for providing improved control and feedback of operating the remote controllable equipment with the robotic surgical tools (Robinson, para [0054]).
Regarding claim 19, Robinson as modified by Shelton and Danziger discloses the surgical control system of claim 17. wherein the control interface is a hand-operable device positioned on an exterior of a surgeon console of the computerized surgical manipulation system, the hand-operable device comprising a plurality of input controls, wherein each of the input controls, when activated, communicate with the operating system of the surgical stapler to perform an action (Robinson at para [0092]-[0093] "Referring now to FIGS. 3A-3C and FIG. 9, a left master controller 905L and a right master controller 905R (including master grip 325) in the workspace 316 can be used to generate control signals for the patient side cart 152 to control the robotic arms and the surgical tools mounted thereto. The left master controller 905L and the right master controller 905R are positioned in the workspace 316 disposed beyond the arm support 314 and below the viewer 312. When using the master control console 150, 150A, the operator O (surgeon or user) typically sits in a chair, moves his or her head into alignment with the viewer 312, and couples his/her fingers to the master grips 325 of left master controller 905L and the right master controller 905R, one in each hand; while resting their forearms against the arm rest 314. This allows the master grips 325 of the left master controller 905L and the right master controller 905R to be moved easily in the control space 316 in both position and orientation to generate control signals."). • ,
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have included the foot operable devices with control as per the other embodiment of Robinson for the system of Robinson and Shelton and Danziger since it allows for providing improved control and feedback of operating the remote controllable equipment with the robotic surgical tools (Robinson, para [0092]-[00931).
Regarding claim 20, Robinson as modified by Shelton and Danziger discloses the surgical control system of claim 17.
Furthermore, Shelton discloses: wherein the control interface is an audio recognition device having a microcontroller (Shelton teaches speech interface recognizes voice commands, para [1094] "Although a foot pedal is shown and described, it is to be understood that the input device 6560 may be a hand controller, a speech interface which accepts voice commands from the surgeon, a· cantilever pedal or other input devices which may be well known in the art of surgical device control. Using the speech interface, the surgeon is able to position a camera or endoscope connected to the robotic arm 6552 using verbal commands.") configured to: (a) receive audio content from an audio capture device. during the minimally invasive procedure, wherein the audio content is one or more instructions from a user; (b) analyze the audio content to determine a meaning for the one or more instructions; and (c) provide a command to the surgical stapler to perform one or more actions based on the meaning of the one or more instructions (Shelton at para 1089]-[1090) "The system 6550 may be adapted and configured to operate a positioning system for an imaging device such as a camera or endoscope using verbal commands. The surgical device 6552 may be a robotic arm which .can hold and move a surgical instrument . The' system 6550 allows the surgeon to control .the operation of the robotic arm 6552 through the input device 6560. ; para [1094] "Although a foot pedal is shown and described, it is to be understood that the input device 6560 may be a hand controller, a speech interface which accepts voice commands from the surgeon, a cantilever pedal or other input devices which may be well known in the art of surgical device control. Using the speech interface, the surgeon is able to position a camera or endoscope connected to the robotic arm 6552 using verbal commands. The imaging device, such as a camera or endoscope, may be coupled to the robotic arm 6552 positioning system that be controlled through the system 6550 using verbal commands.").
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Robinson, Danziger, and Shelton as applied to claim 4 above, and further in view of Wixey et al (JP-6914942-B2 having English equivalent of US-20190038371-A1)(“Wixey ”), all references supplied by Applicant in IDS filed on 10/8/2024.
Regarding claim 5, Robinson as modified by Danziger and Shelton discloses the surgical control system of claim 4.
Furthermore, Shelton discloses: wherein: (a) activation of a first input control opens the clamping mechanism of the end effector; (b) activation of a second input control closes the clamping mechanism of the end effector (para [1082) "The first and second jaws 6532, 6534 are configured to clamp tissue therebetween, fire fasteners through the clamp a tissue, and sever the clamped tissue."; para [1083) "The handle 6504 includes a motor that is coupled to the drive shaft to affect rotation of the drive shaft. The handle 6504 includes a control interface to selectively activate the motor. The control interface may include buttons, switches, levers, sliders, touchscreen, and any other suitable input mechanisms or user interfaces, which can be engaged by a clinician to activate the motor."); and • (d) second activation of the third input control causes the surgical stapler to enter a firing mode (control the firing mode with the switches of the. control interface, para [1082] "The first and second jaws 6532, 6534 are configured to clamp tissue therebetween, fire fasteners through the clamped tissue, and sever the clamped tissue. The first jaw 6532 may be configured to fire at least one fastener a plurality of times, or may be configured to include a replaceable multi-fire fastener cartridge including a plurality of fasteners (e.g.:, staples, clips, etc.) that may be fired more than one time prior to being replaced."; para [1083) "The handle 6504 includes a motor that is coupled to the drive shaft to affect rotation of the drive shaft. The handle 6504 includes a control interface to selectively activate the motor. The control interface may include buttons, switches, levers, sliders, touchscreen, and any other suitable input mechanisms or user interfaces, which can be engaged by a clinician to activate the motor.").
Robinson, Danziger, and Shelton do not explicitly disclose: (c) first activation of a third input control initiates a timeout period before the surgical stapler cuts and staples the anatomical structure of the patient;
However, Wixey discloses: a surgical instrument with an end effect (abstract) and further discloses: (c) first activation of a third input control initiates a timeout period before the surgical stapler cuts and staples the anatomical structure of the patient (para [0041] "In some embodiments, the surgical instrument 200 and I or a related computer support system (for example, a CAD/CAM system 100), these three to distinguish the state to the operator using the user interface. For example, in some embodiments of the pedal, a knob, a button, a switch, and other input devices for changing the state of by a different combination of different control Some embodiments, the timeout (timeout) can also be configured to include a predetermined period of time, whereby the relevant, the first knob operation pedal, and / or the second of the depression, the knob operation, after the first of the pedal, and / or the second of the depression of the pedal is the state associated with the command is brought about. In some embodiments, the surgical instrument 200 (e.g., a computer or a related computer support system includes a user control support system 100), from the viewpoint of "grip" state and the "state" clamping , is in the unfired state, or if the "unfired clamp state" state and a "firing" to prevent user interface. In some embodiments, a single switch or pedal holding state, a state in which to enter the clamp is in the unfired state in order to shift to the is provided to the operator. In some embodiments, a single switch or pedal, the clamp state to enter the firing unfired state in order to shift instruction is provided to the operator."; para [0047) "standby state 460, state machine 400, a predetermined period of time (also referred to as a "rest period" the operation to pause. Standby state 460, in order to stop the operation of the state machine 400 of the actuator speed setpoint is set to zero, by stopping the operation of the actuator, it is possible to pause the actuator. In some cases, the actuator speed setpoint is set to zero by the gripping tissue is further dried to obtain additional time it becomes possible. In some examples, the state machine 400 from the operation of the stapler in order to provide a pause briefly over a predetermined time period remains in the standby state.").
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have included the method of having a timeout period before the. surgical stapler cuts and staples as per Wixey for the system of Robinson and Shelton since it allows for the tissue to be ready for the procedure (Wixey, para [0047]-[0048] and choosing the correct firing control program based on the tissue being treated ( Shelton, para [0482)).
Regarding claim 6, Robinson as modified by Danziger and Shelton and Wixey discloses the surgical control system of claim 5. . wherein the timeout period includes an alert configured to indicate a start of the timeout period, an end of the timeout period, remaining time of the timeout period, or combinations thereof, wherein the alert is a visual indicator, an audio indicator, or combinations thereof (Shelton teaches that the beginning of the sequence can be configured to include the start/end/time of the timeout period which is a step in the sequence, para [0478] "In certain instances, one or more mechanisms and/or sensors such as, for example, sensors 630 can be employed to alert the processor 622 to the program instructions that should be used in a particular setting. For example, the sensors 630 may alert the processor 622 to use the program instructions associated with firing, closing, and articulating the end effector. In certain instances, the sensors 630 may comprise position sensors which can be employed to sense the position of the switch 614, for example. Accordingly, the processor 622 may use the program instructions associated with firing the I-beam of the end effector upon detecting, through the sensors 630 for example, that the switch 614 is in the first position 616; the processor 622 may use the program instructions associated with closing the anvil upon detecting, through the sensors 630 for example, that the switch 614 is in the second position 617; and the processor 622 may use the program instructions associated with articulating the end effector upon detecting, through the sensors 630 for example, that the switch 614 ls in the third or fourth position 618 a, 618 b."; para [0536} "In certain forms, the controller 838 may cause the generator 800 to provide audible or other sensory feedback for alerting the user that a power on or power off sequence has been initiated. Such an alert may be provided at the beginning of a power on or power off sequence and prior to the commencement of other processes associated with the sequence.").
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have included the method of providing an alert. to indicate any step of the sequence as per the other embodiment of Shelton for the system of Robinson, Danziger, Shelton and Wixey since it allows for providing feedback to the user based on various steps such as firing or closing of the instrument ( Shelton, para [0478]).
Regarding claim 7, Robinson as modified by Danziger, Shelton and Wixey discloses the surgical control system of claim 5.
Wixey discloses: wherein the timeout period lasts 15 second (Wixey para [0041 ]) and further discloses: Process 645, ·also the standby (the "pause") is generated. Speed setpoint reaches zero, the end effector, the firing of the predetermined time period (e.g., 1 to 10 seconds) is delayed. (para [0064])).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have arrived by routine experimentation at using any predetermined time as required for the tissue/procedure of Robinson, Danziger, Shelton, and Wixey since it allows for providing the correct firing/gripping/cutting status for the robotic arm as required (Wixey, para [0041]-[00481).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ELLIS B. RAMIREZ/Examiner, Art Unit 3658